https://m2.mtmt.hu/ hun 2026-09-21 03:33 JournalArticle 30710084 ADMIN_APPROVED true 0 false 2026-08-13T08:52:48.952+0000 2020-11-02T10:25:31.845+0000 2019-06-11T08:48:04.374+0000 true 10019983 Parcsami Gáborné /api/admin/10019983 Admin true 10019983 2021-04-01T06:36:26.660+0000 2021-04-01T06:36:26.660+0000 2020-02-19T10:15:36.455+0000 true 10062250 Molnár-Taga Márta /api/admin/10062250 Admin true 10062250 true false true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle true 10000059 Article true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle /api/subtype/10000059 Szakcikk SubType 101 true 10000059 true 1 /api/category/1 Category true 1 Daly, Ella J Efficacy of Esketamine Nasal Spray Plus Oral Antidepressant Treatment for Relapse Prevention in Patients With Treatment-Resistant Depression A Randomized Clinical Trial true true /api/journal/10030683 REVIEWED true false 10030683 false 10030683 true 2168-622X 2168-6238 Journal FOREIGN 76 9 893 903 893 11 2019 Controlled studies have shown short-term efficacy of esketamine for treatment-resistant depression (TRD), but long-term effects remain to be established.To assess the efficacy of esketamine nasal spray plus an oral antidepressant compared with an oral antidepressant plus placebo nasal spray in delaying relapse of depressive symptoms in patients with TRD in stable remission after an induction and optimization course of esketamine nasal spray plus an oral antidepressant.In this phase 3, multicenter, double-blind, randomized withdrawal study conducted from October 6, 2015, to February 15, 2018, at outpatient referral centers, 705 adults with prospectively confirmed TRD were enrolled; 455 entered the optimization phase and were treated with esketamine nasal spray (56 or 84 mg) plus an oral antidepressant. After 16 weeks of esketamine treatment, 297 who achieved stable remission or stable response entered the randomized withdrawal phase.Patients who achieved stable remission and those who achieved stable response (without remission) were randomized 1:1 to continue esketamine nasal spray or discontinue esketamine treatment and switch to placebo nasal spray, with oral antidepressant treatment continued in each group.Time to relapse was examined in patients who achieved stable remission, as assessed using a weighted combination log-rank test.Among the 297 adults (mean age [SD], 46.3 [11.13] years; 197 [66.3%] female) who entered the randomized maintenance phase, 176 achieved stable remission; 24 (26.7%) in the esketamine and antidepressant group and 39 (45.3%) in the antidepressant and placebo group experienced relapse (log-rank P = .003, number needed to treat [NNT], 6). Among the 121 who achieved stable response, 16 (25.8%) in the esketamine and antidepressant group and 34 (57.6%) in the antidepressant and placebo group experienced relapse (log-rank P < .001, NNT, 4). Esketamine and antidepressant treatment decreased the risk of relapse by 51% (hazard ratio [HR], 0.49; 95% CI, 0.29-0.84) among patients who achieved stable remission and 70% (HR, 0.30; 95% CI, 0.16-0.55) among those who achieved stable response compared with antidepressant and placebo treatment. The most common adverse events reported for esketamine-treated patients after randomization were transient dysgeusia, vertigo, dissociation, somnolence, and dizziness (incidence, 20.4%-27.0%), each reported in fewer patients (<7%) treated with an antidepressant and placebo.For patients with TRD who experienced remission or response after esketamine treatment, continuation of esketamine nasal spray in addition to oral antidepressant treatment resulted in clinically meaningful superiority in delaying relapse compared with antidepressant plus placebo.ClinicalTrials.gov identifier: NCT02493868. true 2019 true true true false true false NONE 2026-08-13 false 525 4 525 455 2 523 510 488 347 525 525 455 455 455 70 0 525 455 525 455 0 0 0 Folyóiratcikk Journal Article 24 512 Könyvrészlet Chapter in Book 25 12 Könyv Book 23 1 Egyéb konferenciaközlemény Conference paper 31 0 Egyéb konferenciakötet Conference proceedings 32 0 Oltalmi formák Protection forms 26 0 Disszertáció Thesis 28 0 Egyéb Miscellaneous 29 0 Alkotás Achievement 22 0 Kutatási adat Research data 33 0 Folyóiratcikk Journal Article 24 0 0 0 Könyvrészlet Chapter in Book 25 0 0 0 Könyv Book 23 0 0 0 Egyéb konferenciaközlemény Conference paper 31 0 0 0 Egyéb konferenciakötet Conference proceedings 32 0 0 0 Oltalmi formák Protection forms 26 0 0 0 Disszertáció Thesis 28 0 0 0 Egyéb Miscellaneous 29 0 0 0 Alkotás Achievement 22 0 0 0 Kutatási adat Research data 33 0 0 0 2019 0 11 8 11 8 2020 0 67 55 67 55 2021 0 80 64 80 64 2022 0 68 58 68 58 2023 0 74 62 74 62 2024 0 85 80 85 80 2025 0 103 95 103 95 2026 0 37 33 37 33 D1 false false false false 2019-09-15T13:22:17.594+0000 Pszichiátriai és Pszichoterápiás Klinika (SE / AOK / K) 1 6 1 23 0 true Language 10002 /api/language/10002 Angol English true 2 true PersonAuthorship 87378528 /api/authorship/87378528 1 0.04347826 true false Daly Ella J true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 87378529 /api/authorship/87378529 2 0.04347826 false false Trivedi Madhukar H true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 87378530 /api/authorship/87378530 3 0.04347826 false false Janik Adam true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 87378531 /api/authorship/87378531 4 0.04347826 false false Li Honglan true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 87378532 /api/authorship/87378532 5 0.04347826 false false Zhang Yun true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 87378533 /api/authorship/87378533 6 0.04347826 false false Li Xiang true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 87378534 /api/authorship/87378534 7 0.04347826 false false Lane Rosanne true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 87378535 /api/authorship/87378535 8 0.04347826 false false Lim Pilar true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 87378536 /api/authorship/87378536 9 0.04347826 false false Duca Anna R true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 87378537 /api/authorship/87378537 10 0.04347826 false false Hough David true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 87378538 /api/authorship/87378538 11 0.04347826 false false Thase Michael E true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 87378539 /api/authorship/87378539 12 0.04347826 false false Zajecka John true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 87378540 /api/authorship/87378540 13 0.04347826 false false Winokur Andrew true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 87378541 /api/authorship/87378541 14 0.04347826 false false Divacka Ilona true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 87378542 /api/authorship/87378542 15 0.04347826 false false Fagiolini Andrea true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 87378543 /api/authorship/87378543 16 0.04347826 false false Cubala Wieslaw J true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 87378544 /api/authorship/87378544 17 0.04347826 false false Author 10005190 /api/author/10005190 Bitter István true 10005190 true Bitter István true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 87378545 /api/authorship/87378545 18 0.04347826 false false Blier Pierre true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 87378546 /api/authorship/87378546 19 0.04347826 false false Shelton Richard C true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 87378547 /api/authorship/87378547 20 0.04347826 false false Molero Patricio true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 87378548 /api/authorship/87378548 21 0.04347826 false false Manji Husseini true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 87378549 /api/authorship/87378549 22 0.04347826 false false Drevets Wayne C true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 87378550 /api/authorship/87378550 23 0.04347826 false true Singh Jaskaran B true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PublicationIdentifier 15676781 /api/publicationidentifier/15676781 PlainSource 6 /api/publicationsource/6 PublicationSourceType 10001 /api/publicationsourcetype/10001 true true true DOI DOI https://doi.org/@@@ true true 6 true 10.1001/jamapsychiatry.2019.1189 https://doi.org/10.1001/jamapsychiatry.2019.1189 false true PublicationIdentifier 16837100 /api/publicationidentifier/16837100 PlainSource 1 /api/publicationsource/1 PublicationSourceType 10003 /api/publicationsourcetype/10003 false true true WoS WoS https://www.webofscience.com/wos/woscc/full-record/@@@ true true 1 true IDENTICAL 000490563700007 https://www.webofscience.com/wos/woscc/full-record/000490563700007 true true PublicationIdentifier 17850415 /api/publicationidentifier/17850415 PlainSource 3 /api/publicationsource/3 PublicationSourceType 10003 /api/publicationsourcetype/10003 false true true Scopus Scopus http://www.scopus.com/record/display.url?origin=inward&eid=2-s2.0-@@@ true true 3 true IDENTICAL 85066854122 http://www.scopus.com/record/display.url?origin=inward&eid=2-s2.0-85066854122 true true PublicationIdentifier 15676780 /api/publicationidentifier/15676780 PlainSource 17 /api/publicationsource/17 PublicationSourceType 10003 /api/publicationsourcetype/10003 false true true PubMed PubMed http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=@@@&dopt=Abstract true true 17 true 31166571 http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=31166571&dopt=Abstract false true SjrRating 10990243 /api/sjrrating/10990243 21 0.0 journal RatingType 10002 /api/ratingtype/10002 sjr true true ClassificationExternal 2701 /api/classificationexternal/2701 true 2701 true D1 DIRECT true true /api/publication/30710084 <div class="JournalArticle Publication long-list"> <div class="authors"> <img title="Forrásközlemény" style="float: left" src="/frontend/resources/grid/publication-core-icon.png"> <div class="autype autype0"> <span class="author-name" >Daly Ella J </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Trivedi Madhukar H </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Janik Adam </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Li Honglan </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Zhang Yun </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Li Xiang </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Lane Rosanne </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Lim Pilar </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Duca Anna R </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Hough David </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Thase Michael E </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Zajecka John </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Winokur Andrew </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Divacka Ilona </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Fagiolini Andrea </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Cubala Wieslaw J </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10005190"><a href="/gui2/?type=authors&mode=browse&sel=10005190" target="_blank">Bitter István (<span class="authorship-author-name">Bitter István</span> <span class="authorAux-mtmt"> Elmekórtan</span>) </a> </span> <span class="author-affil"><span title="Semmelweis Egyetem">SE</span>/<span title="Általános Orvostudományi Kar">AOK</span>/<span title="Klinikum">K</span>/Pszichiátriai és Pszichoterápiás Klinika</span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Blier Pierre </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Shelton Richard C </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Molero Patricio </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Manji Husseini </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Drevets Wayne C </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Singh Jaskaran B </span> </div> </div> <div class="title"><a href="/gui2/?mode=browse&params=publication;30710084" target="_blank">Efficacy of Esketamine Nasal Spray Plus Oral Antidepressant Treatment for Relapse Prevention in Patients With Treatment-Resistant Depression : A Randomized Clinical Trial.</a></div> <div> <span class="journal-title">JAMA PSYCHIATRY</span> <span class="journal-issn">(<a target="_blank" href="https://portal.issn.org/resource/ISSN/2168-622X">2168-622X</a> <a target="_blank" href="https://portal.issn.org/resource/ISSN/2168-6238">2168-6238</a>)</span>: <span class="journal-volume">76</span> <span class="journal-issue">9</span> <span class="page"> pp 893-903 </span> <span class="year">(2019)</span> </div> <div class="pub-footer"> <span class="language" xmlns="http://www.w3.org/1999/html">Nyelv: Angol | </span> <span class="identifiers"> <span class="id identifier oa_none" title="none"> <a style="color:black" title="10.1001/jamapsychiatry.2019.1189" target="_blank" href="https://doi.org/10.1001/jamapsychiatry.2019.1189"> DOI </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="000490563700007" target="_blank" href="https://www.webofscience.com/wos/woscc/full-record/000490563700007"> WoS </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="85066854122" target="_blank" href="http://www.scopus.com/record/display.url?origin=inward&eid=2-s2.0-85066854122"> Scopus </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:black" title="31166571" target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=31166571&dopt=Abstract"> PubMed </a> </span> </span> <OnlyViewableByAuthor><div class="ratings"> <div class="journal-subject">Folyóirat szakterülete: Scopus - Medicine (miscellaneous)&nbsp;&nbsp;&nbsp;SJR indikátor:&nbsp;D1</div> <div class="journal-subject">Folyóirat szakterülete: Scopus - Psychiatry and Mental Health&nbsp;&nbsp;&nbsp;SJR indikátor:&nbsp;D1</div> </div></OnlyViewableByAuthor> <div class="publication-citation" style="margin-left: 0.5cm;"> <span title="Nyilvános idézőközlemények összesen, említések nélkül" class="citingPub-count">Nyilvános idéző összesen: 525</span> | Független: 455 | Függő: 70 | Nem jelölt: 0 | WoS jelölt: 488 | Scopus jelölt:&nbsp;347 | WoS/Scopus jelölt:&nbsp;525 | DOI jelölt:&nbsp;510 (Nem nyilvános:&nbsp;4) </div> <div class="mtid"><span class="long-pub-mtid">Közlemény: 30710084</span> | <span class="status-data status-ADMIN_APPROVED"> Admin láttamozott </span> Forrás | <span class="type-subtype">Folyóiratcikk ( Szakcikk ) </span> | <span class="pub-category">Tudományos</span> | <span class="publication-sourceOfData">PubMed (pubmed_result (6).xml, 2019-06-11)</span> </div> <div class="lastModified">Utolsó módosítás: 2020.11.02. 11:25 Parcsami Gáborné (SE_AOK_Pszich_Admin5_PG, admin) </div> </div></div>